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EC number: 232-465-2 | CAS number: 8047-99-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 September 1983 - 30 October 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Pre-GLP period
- Principles of method if other than guideline:
- Test procedures based on the work of Ames et al (1975), "Methods for detecting carcinogens and mutagens with the salmonella mammalian-microsome test"
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-ethyl-o(or p)-toluenesulphonamide
- EC Number:
- 232-465-2
- EC Name:
- N-ethyl-o(or p)-toluenesulphonamide
- Cas Number:
- 8047-99-2
- Molecular formula:
- C9H13NO2S
- IUPAC Name:
- N-ethyl-4-methylbenzene-1-sulfonamide
- Test material form:
- liquid: viscous
- Remarks:
- Colour: light yellow
- Details on test material:
- Ketjenflex 8 (NETSA)
Chemical name in report: N-ethyl-o/p-toluenesulfonamide (or N-substituted toluene sulphonamide)
Description: light yellow viscous liquid
Purity 100% (or 90%)
Test substance storage: at room temperature in the dark
Stability under storage conditions: stable
Constituent 1
- Specific details on test material used for the study:
- - Test Material: Santicizer 8
- Purity: 89%
- Storage condition of test material: stored in the dark at ambient temperature
- Stability under test conditions: indicated not to be unstable to heat, light, and water by the sample submitter
Method
- Target gene:
- Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix ( as described by ames at el.(1975)
- Test concentrations with justification for top dose:
- TA 1535, TA 1537, TA 98, and TA 100 (without and with S9): 0.01, 0.04, 0.20, 1.00, 3.00 and 10.00 mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Solutions of the test material were prepared with ACS grade dimethylsulfoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- benzo(a)pyrene
- other: NaNO2 and 2-aminoanthracene
- Details on test system and experimental conditions:
- DETERMINATION OF CYTOTOXICITY
- Method: on the basis of a decline in the number of spontaneous revertants, a thinning of the background lawn or a microcolony formation
METHOD OF APPLICATION:
- Method: plate incorporation method
DURATION
- Exposure duration: 72 hours at 37 degrees celsius
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain
- Evaluation criteria:
- For the test substance to be considered mutagenic, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels. This was done using statistical methods to evaluate the test results ( see below).
- Statistics:
- Statistical analysis was performed on the plate incorporation assay results after transforming revertant/ plate values as log 10 (revertant/plate). Analysis included Bartlett’s test for homogeneity of variance and comparison of treatments with controls using within-levels pooled variance and a one-sided t-test. Grubb’s test was performed to determine if outliers were present. Dose response was evaluated with regression analysis for log 10 transformed doses and revertants/ plate. Significance of dose-response was evaluated by a t-tester.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Only the maximum concentration of 10 mg per plate was toxic in the test
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Only the maximum concentration of 10 mg per plate was toxic in the test
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Only the maximum concentration of 10 mg per plate was toxic in the test
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Only the maximum concentration of 10 mg per plate was toxic in the test
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was reported
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- In all strains toxicity was observed at the higher doses (at 10 mg /plate), both in the absence and/or presence of S9, with the exception of TA98 (with the absence of S9).
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, Santicizer 8 was determined to be not mutagenic and does not need to be classified for mutagenicity in the Salmonella typhimurium reverse mutation assay.
- Executive summary:
The mutagenic activity of Santicizer 8 was conducted based on test procedures described by Ames et al (1975) according to OECDTG 471 . Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 were treated with the test item using the Ames plate incorporation method at up to six dose levels, in triplicate, both with and without the addition of S9-mix. Adequate negative and positive controls were included. Only four strains of bacteria were used, none of which would be able to detect certain oxidizing mutagens, cross- linking agents and hydrazines as detected by E.Coli WP2 strains or s.typhimurium TA102.
The test material, Santicizer 8, was not mutagenic towards salmonella typhimurium test strains TA98, TA100, TA1535 or TA1537 in the plate incorporation assays conducted with and without a rat microsomal activation system. A maximum of 10 mg per plate was used in the plate incorporation tests. Levels of 10 mg per plate were toxic in the plate incooperation test in the presence and absence of a rat microsomal activation system, whereas the lower concentrations tested were not. The plate incorporation test results indicated no significant mutagenic activity for Santicizer 8, and was therefore considered to be non-mutagenic under the conditions of this test.
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